Chronic liver disease-related liver fibrosis (including etiologies such as hepatitis B, fatty liver disease, autoimmune hepatitis, etc., METAVIR F0–F4)
Conditions
Interventions
Gold Standard:Liver histopathology, specifically EUS-guided liver biopsy (EUS-LB) , with pathological assessment using the METAVIR fibrosis staging system (F0–F4) .
Index test:Olympus EU-ME3 test (EUS-SWQ)
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years and <=80 years; 2. Having a clinical indication and planned to undergo EUS-guided liver biopsy for evaluation of liver pathology, with chronic liver disease meeting criteria for liver biopsy, including: a. hepatitis B; b. fatty liver disease (MASLD/NAFLD); c. autoimmune hepatitis; d. other chronic liver diseases of unknown etiology that may benefit from liver biopsy; 3. Planned to undergo both EUS-SWQ and FibroScan examinations prior to liver biopsy; 4. Willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who cannot tolerate endoscopic examination; 2. Patients with contraindications to endoscopy or anesthesia; 3. Coagulation dysfunction (platelet count 3 seconds above the upper limit of normal); 4. Patients with severe primary diseases of the respiratory, cardiovascular, cerebrovascular, digestive, or hematological systems, as well as those with psychiatric disorders; 5. Patients with surgically altered anatomy that precludes adequate endoscopic ultrasound imaging of the liver parenchyma; 6. Imaging findings suggestive of hepatic malignancy; 7. Pregnant or breastfeeding women; 8. Decompensated cirrhosis (gastrointestinal bleeding, ascites, hepatic encephalopathy); 9. Patients who refuse to participate in the clinical study; 10. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between EUS-SWQ measurements and pathological stages of liver fibrosis;Consistency; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactLi Baiwen
Shanghai General Hospital
Outcome results
None listed